Tainted Heparin May Have Been The Work Of Counterfeiters

The Chicago Tribune is reporting that tainted heparin that killed 19 people may have been the work of counterfeiters:

The U.S. Food and Drug Administration said today drug counterfeiters may have added a foreign ingredient into Chinese shipments of Baxter’s blood-thinner heparin which has been linked to 19 deaths and 800 illnesses.

As much as 25 percent of the material in the nine suspect lots of the blood-thinning drug, sold by Deerfield-based Baxter are a foreign substance that is similar in chemical make-up to heparin, said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.

Conventional quality and safety testing performed by Baxter and its supplier, Scientific Protein Laboratories of Waunakee, Wis., did not show any variation because the foreign substance is so similar to heparin. “It acts like heparin in this test, so it looks like everything is fine in the test,” Woodcock said.

The FDA is investigating where the substance came from and how it got into the heparin:

“We don’t know if this occurred by some error, by some biological process, or if this occurred deliberately,” said Woodcock.

The FDA said that the contaminant is present in the active pharmaceutical ingredient originating from Scientific Protein’s plant in Changzhou, China, but it also is possible that the foreign substance could have been introduced at the company’s Waunakee, Wis. plant or at Baxter’s Cherry Hill, N.J., processing facility.

Dr. Andrew C. von Eschenbach, commissioner of the FDA, declined to say whether or not the FDA actually inspects the facilities in China that produce pharmaceutical ingredients to the U.S., telling the paper: “I hope you’ll put this into a context that addresses the complexity of the problem.”

It you wanted an easy job, Doctor, why are you the commissioner of the FDA?

FDA finds contaminant in Baxter’s blood-thinner heparin [Chicago Tribune] (Thanks, Andrew!)

Comments

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  1. Adam Hyland says:

    “I hope you’ll put this into a context that addresses the complexity of the problem.”

    that’s a “no”, by the way. :)

  2. dweebster says:

    Yes, Free Trade policies with zero accountability seem to be working out real well for the USA. At least they’re able to narrow the possible origination down to only two huge countries…

  3. forgottenpassword says:

    make way for the chinese poison train! WOOOOOOT! WOOOOOT!

  4. weedpindle says:

    Why are we using these additives from China? These companies that use it to make products to sell to world consumers need to be put out of business. Just another in a long line of tainted goods from our friends, the chinese.

  5. bohemian says:

    Chinese crooks are clearly not stupid. The melamine was put in wheat gluten because it tested just like wheat protein.

    So the FDA has zero monitoring on what goes into drugs sold in the US. So then why are we all forced to buy drugs in the US only because they are “safer”.
    A $200 drug here is $19 in India. It makes me wonder what level of monitoring India has on factories and pharmacies. Just to add to your piece of mind, these same factories in India make lots of drugs for US companies.

  6. jamar0303 says:

    You know, maybe things like drugs need to be made in a better-controlled environment?

  7. Crazytree says:

    me Chinese
    I do sin
    adulterate your Heparin

  8. Jaysyn was banned for: http://consumerist.com/5032912/the-subprime-meltdown-will-be-nothing-compared-to-the-prime-meltdown#c7042646 says:

    Well, it was only a matter of time.

    Shouldn’t this be tagged “Chinese Poison Train”?

  9. NoNamesLeft says:

    First they came for the dogs, and I did nothing because I wasn’t a dog. Then they came for the children, and I did nothing because I wasn’t a child…. Now they are coming after me via Heparin…..

  10. backbroken says:

    It’s a good thing the current administration is keeping Americans from buying those cheap Canadian drugs since they may not be as safe as the drugs available here.

  11. theblackdog says:

    Can we require all drugs to be stamped with “Made in China” on the pills?